There’s a need for improved global regulatory alignment on COVID-19 medicines and vaccines – NGOs
The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are committed to working together to ensure that patients have access to safe and effective health products against COVID-19 as early as possible.
The organisations said this will be done while the existing rigorous scientific standards for the evaluation and safety monitoring of treatments and vaccines are maintained at all times.
In their joint statement this week, they reiterated that therapeutics and vaccines against COVID-19 can only be rapidly approved if applications are supported by robust and sound scientific evidence that allows medicine regulators to conclude on a positive benefit-risk balance for these products.
The organisations also pledged to take concrete actions to ensure equitable access to safe, effective and quality-assured medicines for the treatment or prevention of COVID-19 around the world.
In view of the large number of COVID-19 vaccines and treatments under development, and their potentially imminent roll-out, both organizations have joined forces to uphold and promote the most rigorous, evidence-based regulatory practices by supporting the alignment of regulatory processes across all countries.
They further said as in other areas of the pandemic response, multilateral cooperation between regulatory authorities will be critical in ensuring there is a level playing field, that COVID-19 vaccines and medicines are safe, effective and quality-assured, and that all countries may benefit from such products equitably and at the same time.